A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

Karen Lim; Shiao-Yng Chan; Su Lin Lim; Bee Choo Tai; Cammy Tsai; Su Ren Wong; Siew Min Ang; Tong Wei Yew; E Shyong Tai; Eu Leong Yong

doi:10.2196/22147

A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/22147 ◽

2021 ◽

Vol 9 (3) ◽

pp. e22147

Author(s):

Karen Lim ◽

Shiao-Yng Chan ◽

Su Lin Lim ◽

Bee Choo Tai ◽

Cammy Tsai ◽

...

Keyword(s):

Diabetes Mellitus ◽

Weight Loss ◽

Controlled Trial ◽

Intervention Group ◽

Caloric Intake ◽

First Trimester ◽

Control Group ◽

Optimal Weight ◽

Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial (Preprint)

10.2196/preprints.22147 ◽

2020 ◽

Author(s):

Karen Lim ◽

Shiao-Yng Chan ◽

Su Lin Lim ◽

Bee Choo Tai ◽

Cammy Tsai ◽

...

Keyword(s):

Diabetes Mellitus ◽

Weight Loss ◽

Controlled Trial ◽

Intervention Group ◽

Caloric Intake ◽

First Trimester ◽

Control Group ◽

Optimal Weight ◽

Randomized Controlled

BACKGROUND Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. OBJECTIVE This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. METHODS In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. RESULTS In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). CONCLUSIONS Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. CLINICALTRIAL ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7691-3

Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

Efficacy of an Objective Structured Clinical Examination Training Approach for Training Pharmacy Students in Diabetes Mellitus Counseling: A Randomized Controlled Trial

Pharmacy ◽

10.3390/pharmacy8040229 ◽

2020 ◽

Vol 8 (4) ◽

pp. 229

Author(s):

Imaneh Farahani ◽

Samieh Farahani ◽

Maira A. Deters ◽

Holger Schwender ◽

Stephanie Laeer

Keyword(s):

Diabetes Mellitus ◽

Communication Skills ◽

Controlled Trial ◽

Objective Assessment ◽

Intervention Group ◽

Pharmacy Students ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Training Approach

Pharmacists’ tasks are multifaceted and include, for example, vital counseling and communication skills. Objective Structured Clinical Examinations (OSCEs) could be used to train pharmacy students in these skills. Our study sought to determine the efficacy of our OSCE training approach for training pharmacy students’ counseling and communication skills on diabetes mellitus compared to a control group. This randomized controlled study was conducted with pharmacy students using a pre-post-design. The intervention group completed diabetes OSCE training, while the control group solved diabetes patient cases using subjective, objective, assessment, and plan notes. Before and after the respective training, both groups completed OSCEs evaluating counseling and communication skills. Before each OSCE encounter, the participants completed a self-assessment questionnaire and, upon completion of the seminar, filled out a satisfaction survey. The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group. Both groups were generally satisfied with the seminar. These results demonstrate that our OSCE training approach allows for the effective training of pharmacy students’ diabetes counseling and communication skills and suggests the inclusion of such a skill-based approach more widely in pharmacy students’ education.

A Randomized Controlled Trial of an Educational Intervention to Promote Oral and Dental Health of Patients with Type 2 Diabetes Mellitus

10.21203/rs.2.12714/v3 ◽

2020 ◽

Author(s):

Maryam Mallekmahmoodi ◽

Mohsen Shamsi ◽

Nasrin Roozbahani ◽

Rahmatollah Moradzadeh

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Randomized Controlled Trial ◽

Type 2 Diabetes Mellitus ◽

Dental Hygiene ◽

Controlled Trial ◽

Intervention Group ◽

Randomized Controlled

Abstract Background: Diabetes is the most prevalent disease resulted from metabolic disorders. This study aimed to investigate the effect of training based on health belief model (HBM) on oral hygiene-related behaviors in patients with type 2 diabetes mellitus. Methods: This study was conducted as an educational randomized controlled trial (single blind) on 120 patients with type 2 diabetes referring to a diabetes clinic selected through systematic sampling, who were assigned to two groups of control (N=60) and intervention (N=60). The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention. Then, the intervention group received 4 sessions of educational program based on HBM in one month, and the same questionnaire was completed again after 3 months and the data were analyzed through SPSS version 20 software with inferential statistics, t-test, paired t-tests, Chi square, Mann-Whitney test, and Wilcoxon test analysis. Results: Three months after the intervention, awareness of the patients and perceived susceptibility, benefits, self-efficacy, internal cue to action, and performance in oral and dental hygiene-related behaviors had a significant increase in the intervention group (p<0.05). So that the performance of oral and dental hygiene in the intervention group increased from 2.16 ± 0.71 to 3.25 ± 0.49 (p=0.001) after the education. Conclusion: Our results suggest that training patients with diabetes based on HBM as well as through active follow-up can enhance their skills in oral and dental hygiene-related behaviors. Controlling, monitoring and follow-up during the program are also recommended.

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial (Preprint)

10.2196/preprints.17842 ◽

2020 ◽

Author(s):

Tatiana Toro-Ramos ◽

Andreas Michaelides ◽

Maria Anton ◽

Zulekha Karim ◽

Leah Kang-Oh ◽

...

Keyword(s):

Weight Loss ◽

Randomized Controlled Trial ◽

Prevention Program ◽

Diabetes Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Diabetes Prevention Program ◽

Control Group ◽

Significant Weight Loss ◽

Randomized Controlled

BACKGROUND The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). OBJECTIVE This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. RESULTS A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. CONCLUSIONS This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. CLINICALTRIAL ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

Journal of Medical Internet Research ◽

10.2196/16629 ◽

2020 ◽

Vol 22 (5) ◽

pp. e16629 ◽

Cited By ~ 2

Author(s):

Aikaterini Kassavou ◽

Venus Mirzaei ◽

James Brimicombe ◽

Simon Edwards ◽

Efthalia Massou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Control Group ◽

Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

Jurnal Publikasi Kesehatan Masyarakat Indonesia ◽

10.20527/jpkmi.v6i1.6874 ◽

2019 ◽

Vol 6 (1) ◽

Author(s):

Valentina Meta Srikartika ◽

M. Rasyid Akbar ◽

Herningtyas Nautika Lingga

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Randomized Controlled ◽

Significant Difference ◽

Level Of Knowledge ◽

Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/17842 ◽

2020 ◽

Vol 8 (7) ◽

pp. e17842

Author(s):

Tatiana Toro-Ramos ◽

Andreas Michaelides ◽

Maria Anton ◽

Zulekha Karim ◽

Leah Kang-Oh ◽

...

Keyword(s):

Weight Loss ◽

Prevention Program ◽

Diabetes Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Diabetes Prevention Program ◽

Control Group ◽

Significant Weight Loss ◽

Randomized Controlled ◽

Hba1c Levels

Background The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). Objective This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. Methods Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. Results A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. Conclusions This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. Trial Registration ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-001030 ◽

2020 ◽

Vol 8 (1) ◽

pp. e001030 ◽

Cited By ~ 1

Author(s):

Qinglin Lou ◽

Qing Ye ◽

Haidi Wu ◽

Zhiyong Wang ◽

Robert S Ware ◽

...

Keyword(s):

Type 2 Diabetes ◽

Large Scale ◽

Diabetes Management ◽

Controlled Trial ◽

Intervention Group ◽

Mainland China ◽

Outcome Variable ◽

Control Group ◽

Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

Effectiveness of the Beyond Good Intentions Program on Improving Dietary Quality Among People With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Frontiers in Nutrition ◽

10.3389/fnut.2021.583125 ◽

2021 ◽

Vol 8 ◽

Author(s):

Laura A. van der Velde ◽

Jessica C. Kiefte-de Jong ◽

Guy E. Rutten ◽

Rimke C. Vos

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Dietary Quality ◽

Self Management ◽

Control Group ◽

Randomized Controlled

Background and Aims: An appropriate diet is an essential component of the management of Type 2 Diabetes Mellitus (T2DM). However, for many people with T2DM, self-management is difficult. Therefore, the Beyond Good Intentions (BGI) education program was developed based on self-regulation and proactive coping theories to enhance people's capabilities for self-management. The aim of this study was to determine the effectiveness of the BGI program on improving dietary quality among a preselected group of people with T2DM after two-and-a-half years follow-up.Methods: In this randomized controlled trial, 108 people with T2DM were randomized (1:1) to the intervention (n = 56) (BGI-program) or control group (n = 52) (care as usual). Linear regression analyses were used to determine the effect of the BGI program on change in dietary quality between baseline and two-and-a-half years follow-up. In addition, potential effect modification by having a nutritional goal at baseline was evaluated. Multiple imputation (n = 15 imputations) was performed to account for potential bias due to missing data.Results: According to intention-to-treat analysis, participants in the intervention group showed greater improvements in dietary quality score than participants in the control group (β = 0.71; 95%CI: 0.09; 1.33) after follow-up. Having a nutritional goal at baseline had a moderating effect on the effectiveness of the BGI program on dietary quality (p-interaction = 0.01), and stratified results showed that the favorable effect of the intervention on dietary quality was stronger for participants without a nutritional goal at baseline (no nutritional goal: β = 1.46; 95%CI: 0.65; 2.27 vs. nutritional goal: β = −0.24; 95%CI: −1.17; 0.69).Conclusions: The BGI program was significantly effective in improving dietary quality among preselected people with T2DM compared to care as usual. This effect was stronger among participants without a nutritional goal at baseline. A possible explanation for this finding is that persons with a nutritional goal at baseline already started improving their dietary intake before the start of the BGI program. Future studies are needed to elucidate the moderating role of goalsetting on the effectiveness of the BGI program.